Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 017833
Company: BRACCO
Company: BRACCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MACROTEC | TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT | N/A | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/23/1976 | ORIG-1 | Approval | N/A |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/01/2001 | SUPPL-12 | Supplement |
Label is not available on this site. |
||
| 03/21/1994 | SUPPL-11 | Supplement |
Label is not available on this site. |
||
| 10/06/1989 | SUPPL-10 | Supplement |
Label is not available on this site. |
||
| 09/30/1985 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
| 07/06/1984 | SUPPL-7 | Supplement |
Label is not available on this site. |
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| 06/12/1978 | SUPPL-4 | Supplement |
Label is not available on this site. |
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| 07/13/1977 | SUPPL-3 | Supplement |
Label is not available on this site. |
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| 04/25/1977 | SUPPL-2 | Supplement |
Label is not available on this site. |
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| 07/13/1977 | SUPPL-1 | Supplement |
Label is not available on this site. |